Method and apparatus for enhanced delivery of treatment device to the intervertebral disc annulus

- Anulex Technologies, Inc.

The present invention provides methods and devices for enhancing the delivery of treatment devices for treating the annulus of an intervertebral disc. The methods and devices may employ delivery support elements to delivery tools used to deliver expandable treatment devices to the intervertebral disc. Fixation devices and methods are also disclosed, which may help to secure the treatment device in place.

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Description
CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of U.S. patent application Ser. No. 11/120,750 filed May 3, 2005, now U.S. Pat. No. 7,615,076 which is a continuation-in-part of U.S. patent application Ser. No. 10/352,981 filed Jan. 29, 2003 and a continuation-in-part of U.S. patent application Ser. No. 10/327,106 filed Dec. 24, 2002, now U.S. Pat. No. 7,004,970 each of which are continuations-in-part of U.S. patent application Ser. No. 10/133,339 filed Apr. 29, 2002, now U.S. Pat. No. 7,052,516 which is a continuation-in-part of U.S. patent application Ser. No. 09/947,078, filed Sep. 5, 2001, now U.S. Pat. No. 6,592,625, issued Jul. 15, 2003, which is a continuation of U.S. patent application Ser. No. 09/484,706, filed Jan. 18, 2000, now abandoned which claims the benefit of U.S. Provisional Application No. 60/160,710, filed Oct. 20, 1999. This application also claims, through U.S. patent application Ser. No. 10/133,339, the benefit of U.S. Provisional Application No. 60/309,105, filed Jul. 31, 2001. This application is also related to, and claims the benefit of, U.S. patent application Ser. No. 10/075,615, filed on Feb. 15, 2002. All are incorporated herein by reference in their entirety.

FIELD OF THE INVENTION

The invention generally relates to methods and devices for the closure, sealing, repair, augmentation, reconstruction or otherwise treatment of an intervertebral disc annulus, and accompanying delivery devices and tools, and their methods of use. The repair can be of an aperture in the disc wall, or a weakened or thin portion. The term “aperture” refers to a hole in the annulus that is a result of a surgical incision or dissection into the intervertebral disc annulus, or the consequence of a naturally occurring tear (rent). The invention generally relates to surgical devices and methods for the treatment of intervertebral disc wall repair or reconstruction. The invention further relates to an annular repair device, or stent, for annular disc repair. These implants can be of natural or synthetic materials. The effects of said reconstruction is restoration of disc wall integrity, which may reduce the failure rate (3-21%) of a common surgical procedure (disc fragment removal or discectomy), or advantageously provide a barrier to intradiscal material migration. In particular, the invention further relates to an enhanced delivery method and device for the delivery of a patch, mesh, barrier, scaffold, or other implant to treat an intervertebral disc.

BACKGROUND OF THE INVENTION

The spinal column is formed from a number of bony vertebrae, which in their normal state are separated from each other by intervertebral discs. These discs are comprised of the annulus fibrosus, and the nucleus pulposus, both of which are soft tissue. The intervertebral disc acts in the spine as a crucial stabilizer, and as a mechanism for force distribution between adjacent vertebral bodies. Without a competent disc, collapse of the intervertebral disc may occur, contributing to abnormal joint mechanics and premature development of degenerative and/or arthritic changes.

The normal intervertebral disc has an outer ligamentous ring called the annulus surrounding the nucleus pulposus. The annulus binds the adjacent vertebrae together and is constituted of collagen fibers that are attached to the vertebrae and cross each other so that half of the individual fibers will tighten as the vertebrae are rotated in either direction, thus resisting twisting or torsional motion. The nucleus pulposus is constituted of soft tissue, having about 85% water content, which moves about during bending from front to back and from side to side.

The aging process contributes to gradual changes in the intervertebral discs. The annulus loses much of its flexibility and resilience, becoming more dense and solid in composition. The aging annulus may also be marked by the appearance or propagation of cracks or fissures in the annular wall. Similarly, the nucleus desiccates, increasing viscosity and thus losing its fluidity. In combination, these features of the aged intervertebral discs result in less dynamic stress distribution because of the more viscous nucleus pulposus, and less ability to withstand localized stresses by the annulus fibrosus due to its desiccation, loss of flexibility and the presence of fissures. Fissures can also occur due to disease or other pathological conditions. Occasionally fissures may form rents through the annular wall. In these instances, the nucleus pulposus is urged outwardly from the subannular space through a rent, often into the spinal column. Extruded nucleus pulposus can, and often does, mechanically press on the spinal cord or spinal nerve rootlet. This painful condition is clinically referred to as a ruptured or herniated disc.

In the event of annulus rupture, the subannular nucleus pulposus migrates along the path of least resistance forcing the fissure to open further, allowing migration of the nucleus pulposus through the wall of the disc, with resultant nerve compression and leakage of chemicals of inflammation into the space around the adjacent nerve roots supplying the extremities, bladder, bowel and genitalia. The usual effect of nerve compression and inflammation is intolerable back or neck pain, radiating into the extremities, with accompanying numbness, weakness, and in late stages, paralysis and muscle atrophy, and/or bladder and bowel incontinence. Additionally, injury, disease or other degenerative disorders may cause one or more of the intervertebral discs to shrink, collapse, deteriorate or become displaced, herniated, or otherwise damaged and compromised.

Surgical repairs or replacements of displaced or herniated discs are attempted approximately 390,000 times in the USA each year. Historically, there has been no known way to repair or reconstruct the annulus. Instead, surgical procedures to date are designed to relieve symptoms by removing unwanted disc fragments and relieving nerve compression. While results are currently acceptable, they are not optimal. Various authors report 3.1-21% recurrent disc herniation, representing a failure of the primary procedure and requiring re-operation for the same condition. An estimated 10% recurrence rate results in 39,000 re-operations in the United States each year.

Some have also suggested that the repair of a damaged intervertebral disc might include the augmentation of the nucleus pulposus, and various efforts at nucleus pulposus replacement have been reported. The present invention is directed at the repair of the annulus, whether or not a nuclear augmentation is also warranted.

BRIEF SUMMARY OF THE INVENTION

The present inventions provide methods and devices related to enhancing the delivery of devices for reconstruction of the disc wall in cases of displaced, herniated, thinned, ruptured, or otherwise damaged or infirmed intervertebral discs. In accordance with the invention, an enhanced device and method is disclosed for the delivery of devices to treat an intervertebral disc having an aperture, weakened or thin portion in the wall of the annulus fibrosis of the intervertebral disc. Repair, reconstruction, sealing, occluding an aperture, weakened or thin portion in the wall of the annulus may prevent or avoid migration of intradiscal material from the disc space. The method and device of the present invention allows controlled delivery of an expandable device as described in, for example, pending U.S. patent application Ser. No. 11/120,750, filed May 3, 2005. Reference is made to pending applications as listed above for further details about the various treatment devices, their construction and other attributes of their deliveries. This application is to further describe an invention that may be utilized to enhance the delivery of these various implants.

The method and device of the invention includes, in one embodiment, the steps of providing a first delivery tool having a proximal end and a distal end, the distal end carrying a treatment device; introducing the distal end of the first delivery tool at least partially into the intervertebral disc space; and deploying said treatment device said treatment delivery tool also comprising means to enhance the controlled opening of the treatment device.

It is also anticipated that the treatment devices and their delivery tools may be used in combination with fixation devices as described in previous pending applications identified above.

The objects and various advantages of the invention will be apparent from the description which follows. In general, the implantable medical treatment devices are placed, positioned, and subsequently affixed in the annulus to reduce re-extrusion of the nucleus or other intradiscal material through an aperture by: establishing a barrier or otherwise closing or partially closing an aperture; and/or helping to restore the natural integrity of the wall of the annulus; and/or promoting healing of the annulus. Increased integrity and faster and/or more thorough healing of the aperture may reduce future recurrence of herniation of the disc nucleus, or intradiscal material, from the intervertebral disc, and the recurrence of resulting radicular or back pain. In addition, it is believed that the repair of the annular tissue could promote enhanced biomechanics and reduce the possibility of intervertebral disc height collapse and segmental instability, thus possibly avoiding recurrent radicular or back pain after a surgical procedure.

Moreover, the repair of an annular aperture (after for example, a discectomy procedure) with the reduction of the re-extrusion of the nucleus may also advantageously reduce adhesion formation surrounding the nerve roots. The nuclear material of the disc is toxic to the nerves and is believed to cause increased inflammation surrounding the nerves, which in turn can cause increased scar formation (adhesions or epidural fibrosis) upon healing. Adhesions created around the nerve roots can cause continued back pain. Any reduction in adhesion formation is believed to reduce future recurrence of pain.

Annular repair devices and methods may create a mechanical barrier to the extrusion of intradiscal material (i.e., nucleus pulposus, or nuclear augmentation materials) from the disc space, add mechanical integrity to the annulus and the tissue surrounding an aperture, weakened, or thin portion of the wall of the annulus, and promote faster and more complete healing of the aperture, weakened or thin portion.

Although much of the discussion is directed toward the repair of the intervertebral disc after a surgical procedure, such as discectomy (a surgical procedure performed to remove herniated fragments of the disc nucleus), it is contemplated that the devices of the present invention may be used in other procedures that involve access (whether induced or naturally occurring) through the annulus of the intervertebral disc, or prophylactic application to the annulus. An example of another procedure that could require a repair technique involves the replacement of the nucleus (nucleus replacement) with an implantable nucleus material to replace the functioning of the natural nucleus when it is degenerated. The object of the invention in this case would be similar in that the repair would maintain the replacement nucleus within the disc space.

According to one embodiment of the present invention, treatment delivery devices such as the delivery devices described in FIGS. 43 to 46 and FIGS. 57 to 64 may be used to place an annular treatment devices which are employed to repair an aperture, degenerated, weakened, or thin portion in an intervertebral disc annulus. Placement of a treatment device as depicted, for example, in FIGS. 43 to 46 into disc tissue below the surface of an annular aperture and deploying the device to reach an optimal configuration to occlude, close, repair, augment, or otherwise treat an aperture, weakened or thin portion of the annulus fibrosus may be challenging since the device is placed with little direct visualization. A treatment device placed below the surface of the annulus is preferably inserted into the disc with a diminished dimension to allow the device to be placed through and below the aperture surface, while preferably obtaining a delivery and deployed state that is larger, acting to bridge the aperture below the outer annular surface. Since a surgeon is unable to visualize the delivery of the implant into an “open”, deployed configuration, the ability to assure that the device reliability obtains the desired, open configuration is important. Complicating the delivery is the need for the treatment device to be able to move or push softer tissue aside (i.e., nucleus pulposus and inner layers of annulus fibrosus) during delivery to appropriately situate itself in a bridging relationship over the aperture, weakened, or thin portion of the annulus needing repair. Moreover, the delivery device of the present invention also allows for the surgeon to be able to deploy the device in the subannular space and “seat” (e.g., pulling the delivery device in a proximal direction) the implant device against inner layers of the annulus without deforming the device in a manner that may compromise the implant's ability to reach a maximal deployment. The following description is exemplary of an enhanced delivery device that provides for increased “leverage” in the delivery and the deployment of a patch that is delivered to the intervertebral disc requiring repair, whether or not there may be additional elements of the device to further acutely secure the device to disc tissue, such as sutures, staples, anchor bands, barbs, tension bands, adhesives, or other acute fixation elements known to those skilled in the art.

The inventive treatment delivery device can be used with a variety of repair devices to seal, reconstruct and/or repair the intervertebral disc, as described in other pending applications, for example, implant devices found in FIGS. 2-4, 9, 10, 12-20, and 27-32. This list is not intended to be exclusionary but rather exemplary. In some of the devices described therein, there is: a reconfigurable device (note: patch, stent, implant, device, mesh, barrier, scaffold and treatment device are here used interchangeably) that has, in use, at least a portion of the device in the sub-annular space of the intervertebral disc annulus. In particular, the enhanced delivery device of the present invention will be described in further detail with respect to one of the embodiments of an annular patch delivery, as seen in FIGS. 33 to 64. The description is not intended to be exclusive to the delivery of the braided treatment device, but it is intended to exemplify the use of an enhanced delivery tool and one skilled in the art could readily apply the invention in a variety of delivery devices and repair implants

Some of the concepts disclosed hereinbelow may advantageously additionally incorporate design elements to reduce the number of steps (and time), and/or simplify the surgical technique, and/or reduce the risk of causing complications during the repair of the intervertebral disc annulus. In addition, the following treatment devices may become incorporated by the surrounding tissues, or to act as a scaffold in the short-term (3-6 months) for tissue incorporation, creating a subannular barrier in and across the aperture by placement of a patch of biocompatible material acting as a bridge or a scaffold, providing a platform for traverse of fibroblasts or other normal cells of repair existing in and around the various layers of the disc annulus.

Additional objects and advantages of the invention will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of the invention. The objects and advantages of the invention will be realized and attained by means of the elements and combinations particularly pointed out in the appended claims.

It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the invention, as claimed.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate illustrative embodiments of the invention and, together with the description, serve to explain the principles of the invention.

FIG. 1 shows a primary closure of an opening in the disc annulus.

FIGS. 2 and 2A show a primary closure with a stent.

FIGS. 3A-3D show an annulus stent being inserted into and expanded within the disc annulus.

FIGS. 4A-4C shows a perspective view of a further illustrative embodiment of an annulus stent, and collapsed views thereof.

FIGS. 5A-5C show the annulus stent of FIG. 4A being inserted into the disc annulus.

FIGS. 6A-6C show a method of inserting the annulus stent of FIG. 4A into the disc annulus.

FIG. 7 shows an illustrative embodiment of an introduction device for an annulus stent.

FIG. 8 shows a variation of the device depicted in FIG. 7.

FIGS. 9A-9C show an exemplary introduction tool for use with the devices of FIGS. 7 and 8 with a stent deflected.

FIGS. 10A-10B show a still further illustrative embodiment of an annulus stent employing secondary barbed fixation devices.

FIG. 11A shows a herniated disc in perspective view, and FIG. 11B shows the same disc after discectomy.

FIGS. 12A-12G show a still further illustrative embodiment of an introduced and expanded annulus stent/patch being fixated and the aperture reapproximated.

FIGS. 13A-13C schematically depict a still further embodiment of the invention where an expandable stent/patch is tethered in situ using a cinch line.

FIGS. 14A-14C schematically depict the patch of FIG. 13 being fixated through use of a barbed surgical staple device and a cinch line.

FIGS. 15A-15C schematically depict a still further embodiment of the invention where an expandable stent/patch is tethered in situ using a cinch line.

FIGS. 16A-16C schematically depict the stent/patch of FIG. 15 being fixated through use of a barbed surgical staple device that penetrates the patch/stent and a cinch line.

FIG. 17 depicts an exemplary use of filler material within the aperture during placement of a patch/stent tethered by a cinch line.

FIGS. 18A-18E show exemplary embodiments of various additional patch/stent fixation techniques.

FIG. 19 shows a still further illustrative embodiment of a stent/patch having a frame.

FIGS. 20A-20C show a still further exemplary embodiment of the invention having external fixation anchors.

FIGS. 21A-21C show still further embodiments of the invention having external fixation anchors.

FIGS. 22A-22C show still further embodiments of the invention having external fixation anchors.

FIG. 23 shows a delivered configuration of fixation means that may result from the use of a single, or multiple, devices to deliver multiple barbs, anchor, or T-anchors sequentially or simultaneously.

FIGS. 24A-24B show an illustrative configuration of an anchor band delivery device.

FIGS. 25A-25D show an anchor band delivery device comprising two devices, each with at least one T-anchor (barbs) and band with pre-tied knot and optional knot pusher according to illustrative embodiments of the invention.

FIG. 26 shows an anchor and band delivery device according to one embodiment of the invention.

FIGS. 27A-27B show, respectively, a lateral view of a still further exemplary embodiment of the present invention having a braided arrangement in a collapsed configuration and an axial view of the exemplary embodiment in an expanded configuration.

FIG. 28 shows a lateral view of the exemplary embodiment of FIG. 27A in a collapsed configuration mounted on an illustrative delivery device.

FIG. 29 shows a lateral cutaway view of the exemplary embodiment of FIG. 27A in a collapsed configuration.

FIG. 30 shows a lateral cutaway view of the exemplary embodiment of FIG. 27B in an expanded configuration.

FIG. 31 shows a lateral view of an illustrative delivery member as shown in the exemplary embodiment of FIGS. 29 and 30.

FIG. 32 shows a lateral view of an exemplary embodiment of the invention in an expanded configuration subannularly.

FIG. 33 shows a transverse view of a treatment device mounted on a delivery tool in an unexpanded configuration in the subannular cavity.

FIG. 34 shows a transverse view of the treatment device being deployed into an expanded configuration in the subannular cavity.

FIG. 35 shows a transverse view of the treatment device fully deployed and adjacent the annular wall.

FIG. 36 shows a transverse view of the placement of a fixation element delivery device into the deployed treatment device.

FIG. 37 shows a transverse view of the placement of a fixation element through the treatment device and the annular wall.

FIG. 38 shows a transverse view of after affixing a fixation element delivered in FIG. 37 and partial removal of the fixation element delivery device.

FIG. 39 shows a transverse view of the fixation element after removal of the fixation element delivery tool.

FIG. 40 shows a transverse view of an additional fixation element locked in place on the opposite side of the treatment device.

FIG. 41 shows a transverse view of the removal of the treatment device delivery tool.

FIG. 42 shows a sagittal view of an illustrative embodiment of a treatment device mounted on a delivery tool in an unexpanded configuration in the subannular cavity.

FIG. 43 shows a sagittal view of after affixing a fixation element to the treatment device of FIG. 42.

FIG. 44 shows a sagittal view of the placement of a fixation element delivery tool through the treatment device and the annular wall.

FIG. 45 shows a sagittal view of the placement of an additional fixation element through the treatment device and the annular wall.

FIG. 46 shows a sagittal view after the removal of the fixation element delivery tool.

FIG. 47 is a view of the anchor band delivery tool pre-deployment in cross section.

FIG. 48 shows a detail of the distal end of the anchor band (fixation element) delivery tool in cross section.

FIG. 49 shows a detail of the slide body and cannula anchor of an exemplary fixation element delivery tool in cross section.

FIG. 50 is a view of the anchor band delivery tool in cross section during a deployment cycle.

FIG. 51 is a detail of the distal end of the anchor band delivery tool depicted in FIG. 50.

FIG. 52 shows a detail of the slide body and cannula anchor of an exemplary fixation element delivery tool in cross section during a deployment cycle.

FIG. 53 shows a detail of the suture retention block and blade assembly of the anchor band delivery tool.

FIG. 54 is a view of the anchor band delivery tool in cross section during the cutting of the suture tether and release of the anchor band.

FIG. 55 shows a detail of the distal end of the anchor band delivery tool during release of the anchor band.

FIG. 56 shows a detail of the suture retention block and blade assembly of the anchor band delivery tool during the cutting of the tether shows a detail of the suture retention block and blade assembly of the anchor band delivery tool during the cutting of the tether.

FIG. 57 depicts an illustrative embodiments of a therapeutic device delivery tool (TDDT).

FIG. 58 shows a detail of the distal end of the therapeutic device delivery tool with a therapeutic device mounted thereon.

FIG. 59 depicts the deployment of a therapeutic device using the TDDT.

FIG. 60 depicts a detail of the distal end of the TDDT during deployment of a therapeutic device.

FIG. 61 depicts the TDDT during release of the therapeutic device.

FIG. 62 is a detail view of the distal end of the TDDT during release of the therapeutic device.

FIG. 63 is a plan view along the axis of an expanded exemplary therapeutic device, showing the engagement of the TDDT latch.

FIG. 64 is a plan view along the axis of an expanded exemplary therapeutic device, showing the disengagement of the TDDT latch.

FIG. 65 shows a sagittal view of an illustrative embodiment of a treatment device mounted on a delivery tool in an unexpanded configuration in the subannular cavity, with enhanced delivery support element 540.

FIG. 66 shows a sagittal view of FIG. 65 after deployment and seating of the treatment device.

FIG. 67 depicts illustrative embodiments of the proximal end of a therapeutic device delivery tool (TDDT) with enhanced delivery support elements 540 prior to treatment device deployment.

FIG. 68 depicts illustrative embodiments of the proximal end of a therapeutic device delivery tool (TDDT) with enhanced delivery support elements 540 during treatment device deployment.

FIG. 69 depicts detail illustrative embodiments of the distal end of the TDDT with an enhanced delivery support elements 540 during deployment of a therapeutic device.

FIG. 70 depicts illustrative embodiments of the proximal end of a therapeutic device delivery tool (TDDT) with enhanced delivery support elements 540 after deployment of a treatment device.

FIG. 71 depicts detail illustrative embodiments of the distal end of the TDDT with an enhanced delivery support elements 540 after deployment of a therapeutic device.

FIG. 72 illustrates an alternative embodiment of the distal portion of the TDDT during the deployment of a therapeutic device with delivery support elements 540 and a element collar 544.

FIG. 73 illustrates an alternative embodiment of the distal portion of the TDDT during the deployment of a therapeutic device with delivery support element 540.

FIG. 74 illustrates an alternative embodiment of the distal portion of the TDDT and treatment device during the deployment of a therapeutic device and with delivery support element 540 that may be integral with the treatment device.

FIG. 75 illustrates an alternative embodiment of the distal portion of the TDDT and treatment device during the deployment of a therapeutic device and with delivery support element 540 that may be integral with the treatment device.

 DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS OF THE INVENTION

Reference will now be made in detail to selected illustrative embodiments of the invention, with occasional reference to the accompanying drawings. Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts.

As discussed in previous pending applications, it is understood that there can be a variety of device designs of patches/stents/implants/meshes/devices/treatment devices to repair damaged annular tissue and/or otherwise facilitate maintaining other intradiscal materials within the disc space. These devices can be constructed of single components or multiple components, with a variety of different materials, whether synthetic, naturally occurring, recombinated (genetically engineered) to achieve various objectives in the delivery, deployment and fixation of a device to repair or reconstruct the annulus. The following device concepts are further discussed for additional embodiments of a device and/or system for the repair of an intervertebral disc annulus. The following descriptions will illustratively depict and describe methods, devices, and tools to deliver a treatment to an intervertebral disc after a, lumbar discectomy procedure; although, it is anticipated that these methods, devices, and tools may be similarly used in a variety of applications. As an example, the embodiments described herein may also advantageously maintain materials within the disc space other than natural disc tissue (nucleus, annulus, cartilage, etc.), such as implants and materials that may be used to replace and/or augment the nucleus pulposus or other parts of disc's tissues. These procedures may be performed to treat, for example, degenerative disc disease. Whether these materials are intended to replace the natural functioning of the nucleus pulposus (i.e., implantable prosthetics or injectable, in-situ curable polymer protein, or the like) or provide a fusion between vertebral bodies (i.e., implantable bony or synthetic prosthetics with materials to facilitate fusion, such as growth factors like bone morphogenic proteins) one skilled in the art would realize that variations to the embodiments described herein may be employed to better address characteristic differences in the various materials and/or implants that could be placed within the intervertebral disc space, and that these variations would be within the scope of the invention.

Furthermore, it should be noted that surgeons differ in their techniques and methods in performing an intervention on a spinal disc, and the inventive descriptions and depictions of methods, devices and delivery tools to repair annular tissue could be employed with a variety of surgical techniques; such as, but not limited to: open surgical, microsurgical discectomy (using a magnifying scope or loupes), minimally invasive surgical (through, for example, a METRx™ system available from Medtronic, Inc.), and percutaneous access. Surgeons may also employ a variety of techniques for intra-operative assessment and/or visualization of the procedure, which may include: intra-operative probing, radiography (e.g., C-arm, flat plate), and endoscopy. It is contemplated that the inventive embodiments described are not limited by the various techniques that may be employed by the surgeon.

In addition, the surgical approach to the intervertebral disc throughout the figures and descriptions depict a common approach, with related structures, to a lumbar discectomy; although, it is possible that surgeons may prefer alternative approaches to the intervertebral disc for various applications (for example, different intervertebral disc levels such as the cervical or thoracic region, or for nucleus augmentation), which may include, but is not limited to: posterior-lateral, anterior, anterior-lateral, transforaminal, extra-foraminal, extra-pedicular, axial (i.e., through the vertebral bodies), retroperitoneal, trans psoas (through the Psoas muscle), contralateral, and along the spinal foramen. The approach to the intervertebral disc space should not be interpreted to limit the use of the invention for the repair or reconstruction of the an aperture, weakened or thin portion of the annulus, as described herein.

It is also important to note that the boundary in the intervertebral disc space between the annulus fibrosus and the nucleus pulposus as depicted herein may be demarked or otherwise highlighted; however, it is important to recognize that these tissues are not as precisely demarked in human tissues, and may be even less so as the patient ages or evinces degeneration of the intervertebral disc. This demarcation may be especially difficult to discern during an operative procedure, using for example; available surgical tools (i.e., probes), fluoroscopic guidance (x-ray), or visual (endoscope) guidance. However, in general, the layers of the annulus have more structural integrity (and strength) than the nucleus, and this integrity varies from the outer most layers of the annulus being of higher structural integrity than the inner most layers of the annulus.

Moreover, the drawings and descriptions herein are necessarily simplified to depict the operation of the devices and illustrate various steps in the method. In use, the tissues may be manipulated by, and are frequently in contact with, the various tools and devices; however, for clarity of construction and operation, the figures may not show intimate contact between the tissues the tools and the devices.

As depicted in FIG. 11A, a herniated disc occurs when disc nucleus material emerges from the subannular region and outside of the disc. Herniated disc nucleus material then impinges on nerve tissue, causing pain. A discectomy attempts to relieve pressure on the nerve tissue through surgical removal of disc material, the result usually being an aperture in the disc annulus wall, and usually a void in the subannular space where disc nucleus was removed, as shown in FIG. 11B. FIG. 11B typifies a disc after the discectomy procedure has been performed, as do most of the drawings and descriptions contained herein. However, it should be understood that in order to perform a discectomy procedure, there are a variety of instruments and tools readily available to the surgeon during spine surgery, or other surgical procedures, to obtain the outcome as shown in FIG. 11, or other outcomes intended by the surgeon and the surgical procedure. These tools and instruments may be used to: incise, resect, dissect, remove, manipulate, elevate, retract, probe, cut, curette, measure or otherwise effect a surgical outcome. Tools and instruments that may be used to perform these functions may include: scalpels, Cobb elevators, Kerrison punch, various elevators (straight, angled, for example a Penfield), nerve probe hook, nerve retractor, curettes (angled, straight, ringed), rongeurs (straight or angulated, for example a Peapod), forceps, needle holders, nerve root retractors, scissors. This list is illustrative, but is not intended to be exhaustive or interpreted as limiting. It is anticipated that some of these tools and/or instruments could be used before, during, or after the use of the inventive methods, devices and tools described herein in order to access, probe (e.g., Penfield elevator), prepare (e.g., angled or ringed curette, rongeur, forceps), and/or generally assess (e.g., angled probe) treatment site or facilitate the manipulation (e.g., forceps, needle holder), introduction (e.g., forceps, needle holder, angled probe), or deployment (e.g., forceps, needle holder, angled probe) of the treatment device and/or it's components.

The are a variety of ways to affix a device to the wall of the annulus in addition to those discussed hereinabove. The following exemplary embodiments are introduced here to provide inventive illustrations of the types of techniques that can be employed to reduce the time and skill required to affix the patch to the annulus, versus suturing and tying a knot.

An exemplary embodiment of the enhanced method and device of a treatment delivery tool is the description of an enhanced delivery of the braided device as depicted in FIGS. 24 to 32, FIGS. 33 to 46, and FIGS. 57 to 64. As described previously in pending U.S. patent application Ser. No. 11/120,750, FIGS. 33-46 depict an illustrative method for the deployment of a treatment device into the intervertebral disc 200. As described previously, there are a variety of applications, approaches, techniques, tools, and methods for accessing and performing spinal disc surgery which may be dependent on physician preferences and could be arbitrary. Therefore, the following description and depiction of the method should be considered illustrative and not limiting. In the illustrative scenario which is used in the following descriptions, and with reference to FIG. 33, the disc 200, which is comprised of the annulus fibrosus 202 and the nucleus pulposus 204, is shown in a transverse cross section. The disc 200, as described above, is disposed anatomically between caudal and cephalad vertebral bodies, which a portion of a vertebral body (spinous process 206) seen in FIG. 30. The disc 200 may be accessed for treatment via a surgical incision 208 made in the paramedian region lateral of the spinal canal 210. A microdiscectomy procedure may precede the placement of a treatment device in order to remove disc fragments and to provide a subannular cavity 212. The subannular cavity 212, however, may be preexisting or may be created for the purpose of performing a nuclear augmentation An aperture 214 in the annulus provides a path for the mesh or treatment device delivery tool 500 to place treatment device 600. The treatment device 600 can take the form as described in the embodiments above, or as additionally described below with reference to FIGS. 63-64, as described in commonly-assigned copending U.S. patent application Ser. No. 10/352,981, filed on Jan. 29, 2003 and incorporated herein by reference, or any other appropriate form. Likewise, the anchor band delivery device 400 can take the form as described in the embodiments above, or as additionally described below with reference to FIGS. 47-52, as described in commonly-assigned copending U.S. patent application Ser. No. 10/327,106, filed on Dec. 24, 2002 and incorporated herein by reference or any other appropriate form.

As shown in FIG. 33, a delivery device 500 is introduced through surgical incision 208 to traverse aperture 214 and position treatment device 600 in subannular cavity 212. As depicted, treatment device 600 is in a first configuration sized to permit its passage to the subannular cavity 212. FIG. 42 shows a detail, sagittal view of mesh device 600 mounted on the distal portion 602 of delivery tool 500, introduced to the cavity. Also shown are sections of intervertebral disc tissues. As illustrated, treatment device 600 may have element 608 to latch the mesh device once deployed into its final deployed configuration. If required, there may be a variety of ways to latch, lock or otherwise secure the device in its final configuration, as described previously, or additionally depicted and described below in FIGS. 71A-E.

As depicted in FIG. 34, the treatment device delivery tool 500 can be manipulated by, for example, pulling a finger grip 502 in the direction of arrow 300 to deploy treatment device 600 in the subannular cavity 212. As illustrated here, this deployment involves a longitudinal shortening of the treatment device, drawing end 606 toward end 604, resulting in a lateral expansion of the treatment device 600. The pulling of the finger grip 502 may be preceded by the release of a safety lock 504 preventing deployment of the treatment device until intended by the surgeon. As illustrated here, the lock is released through rotation of handle member 504 in the direction of arrow 302. Also shown is a marking 538 on the delivery tool 500 that may visually assist the surgeon in assessing the degree to which the device has been placed in subannular space.

FIG. 35 shows the finger grip 502 reaching its intended limit, and the concomitant full intended deployment of treatment device 600, where end 606 reaches its intended design position for the deployed configuration of the device 600. In this illustrative depiction, end 606 is pulled adjacent to end 604, and device 600 has reached its maximum intended lateral expansion. As shown, the deployed device 600 may be pulled to internally engage and at least partially conform to the cavity 212. Naturally, the full travel of the finger grip 502 can be determined by the design of the delivery device, or informed by the judgment of the surgeon through visualization, tactile realization, or the like. Once the intended limit has been achieved and the device fully deployed, the delivery device 500 can lock finger pull 502 in place so as to maintain the treatment device 600 in the deployed configuration. It may also be advantageous for the delivery tool 500 to have a perceptible (i.e., audible, tactile, visual) indication that the treatment device has been fully deployed. The mesh/patch delivery tool 500 may be of the type described hereinabove, or as additionally described in FIGS. 57-62 below, or in other sections of this disclosure.

An enhancement to the delivery of the treatment device 600 with mesh delivery tool 500 may include delivery support elements that project from the mesh delivery tool 500 to further enhance the deployment shape and configuration of the treatment device during deployment and “seating” of the device against annular tissue. FIG. 65 shows a detail, sagittal view of mesh device 600 mounted on the distal portion 602 of delivery tool 500, introduced to the cavity having two delivery support elements 540 passing along the axis of the delivery tool 500 and attached to the treatment device 600. The delivery support elements 540 as shown in FIG. 65 may be of a variety of constructions and materials; although, as depicted in one embodiment of the invention in FIG. 65, they represent sutures or tethers used to support the delivery of the treatment device. Generally, each delivery support element in FIG. 65 is a suture line that follows a “looped” pathway from the proximal end of the delivery tool to the distal end of the delivery tool, through the treatment device, and returns back to the proximal end of the delivery tool, wherein each end of the suture is attached to a proximal actuating member of the delivery device, such as finger grip assembly 502. Distally, and in more detail as seen in FIG. 69, the suture line of delivery support element 540 passes: through a proximal portion of the mesh into a distal portion within the mesh (540′—the proximal detachable portion of 540), out of the mesh and back into the mesh in a distal portion of the treatment device, and then back out of a proximal portion of the mesh. Upon deployment of mesh delivery tool 500, delivery support elements assist in the deployment of the treatment device 600 and facilitate “seating” of treatment device 600, as may be required, to a final configuration that abuts, conforms, or otherwise is in proximity to the tissues in need of repair, as shown FIG. 66. FIG. 66 is similar to FIG. 43 except that the delivery tool is enhanced with delivery support elements 540. Delivery support elements 540 advantageously provide increased “leverage” by treatment delivery device 500 to controllably deliver, deploy and open a treatment device in a locale and configuration as desired. Additionally, the delivery support elements allow a surgeon to “pull back” and seat a treatment device against more rigid tissue, such as the outer layers of the annulus, while not buckling or otherwise deforming the treatment device during the seating process as it is pulled through softer tissues such as nucleus pulposus and the inner layers of the annulus fibrosus. Importantly, the delivery support elements allow a more reliable delivery of a treatment device which is extremely important for a surgeon since there is no easy way to visualize adequate delivery of the implant.

FIGS. 65 and 66 depict a mesh delivery tool 500 having two delivery support members 540 arranged in a caudal/cephalad arrangement, although the number of delivery support elements and their arrangement could be varied depending on the treatment device support needed and the final deployed configuration desired. For example, delivery tool 500 could be constructed to use only a single delivery support member 540 to direct the deployment of the treatment device in a single direction. Alternatively, multiple support elements can be used to control the mesh deployment in multiple directions, for example, in four directions—medial, lateral, cephalad and caudal, or any other arrangement that advantageously situates the treatment device in a desired configuration. FIGS. 65 and 66 depict an arrangement of the delivery support elements being located cephalad and caudal to an annular aperture, although this is for illustration purposes only and a medial/lateral arrangement could also be employed.

Controlled delivery, seating and deployment of the treatment device may also be beneficial in optimally opening the treatment device to accommodate the fixation of the device to annular tissue, with various means as described herein.

Although the previous description describes the deployment of the support elements as being attached to the same actuator as the treatment device, and delivered at the same time as the deployment of the treatment device, it is also possible that separate actuators could be employed to deliver the functioning of the support elements separately from the treatment. For example, support elements may be attached to a separate actuator to actuate the support elements before, during, or after the deployment of the treatment device.

FIG. 36 next depicts a fixation element or anchor band delivery device 400 introduced through surgical incision 208, where the distal end 402 is passed through the annulus fibrosus 202 adjacent to the aperture 214, and subsequently through treatment device 600, as illustrated by arrow 190. Fixation element delivery tool 400 may have features to provide tactile feedback once the delivery tool has been introduced into tissue to an acceptable extent, for example a feature like tissue-stop 432. As illustrated, delivery device 400 is passed distally until stop 432 and pledget member 309 of the fixation device 308 come in contact with the outer surface of the annulus. Alternatively, and without tissue stop 432 use, pledget member 309 could be of construction to similarly resist, or otherwise visually or tactilely indicate ceasing the passage of delivery device 400 through annular tissue. FIG. 44 shows a detail, sagittal view of a distal end of a fixation element delivery tool 400 introduced into disc tissue and through treatment patch 600. As shown in FIG. 44, one fixation element has been deployed and fixated. FIG. 44 also depicts an exemplary treatment device detection feature 442 on the outer surface of needle cannula 428, as more clearly illustrated in FIG. 48. The patch detection feature 442 on the distal end of needle cannula 428 may advantageously provide perceptible feedback (tactile and/or audible) to the surgeon that the anchor band delivery tool has accessed and penetrated the patch and it is therefore acceptable to deliver the band. Feature 442 is discussed in more detail below. In operation as illustrated in FIG. 36 and in FIG. 37, the delivery device 400 can be manipulated similarly to the treatment device delivery tool. For example, moving finger grip 404 in the direction of arrow 304 will withdraw a portion (for example, the slotted needle cannula 428) of distal end 402 of the device 400 and deploy a fixation element 308, as more described below, in the subannular cavity 212 to secure the treatment device 600. The pulling of the finger grip 404 may be preceded by the release of a safety lock 406 preventing deployment of the fixation element until intended by the surgeon. As illustrated here, the safety 406 is released through rotation of safety 406 in the direction of arrow 306. The fixation element delivery tool 400 may be of the type described hereinabove, or as additionally described in FIGS. 47-56 below, or in other areas of this disclosure

FIG. 37 depicts the deployment of a fixation element, 308 into disc tissue following the deployment of FIG. 36. The fixation device may be as described above, for instance a T-anchor, suture, tether, knot, pledget or barb. As illustrated here, the fixation element 308 is a T-anchor with suture bodies, knot, and pledget as more fully described below. During the pulling of finger grip 404 and retraction of slotted needle cannula 428, a knot pusher end 406 of inner cannula 426 is shown holding a proximal portion of the fixation device's 308 slip knot 440, while T-anchor 316 is drawn in tension proximally by tether or suture line 310, to adjust the length of the fixation element 308 to provide the proper tension to securely hold the treatment device 600 in situ. A proximal end of the fixation element, such as a pledget 309, is held or urged into engagement with a bearing surface on the exterior of the annulus. The proximal end of the fixation device can also include a T-anchor or knot or similar tissue locking element. FIG. 48 is a cross sectional view of the distal end of delivery tool 400 as it may be introduced in disc tissue. FIG. 55 shows the distal end of the delivery tool 400 after retraction of the slotted needle cannula 428 and tensioning and drawing T-anchor 316 proximally to a potential final state. The proximal drawing of T-anchor 316 is also illustrated in a detail, sagittal view in FIG. 45, with arrows 324 illustrating motion of the T-anchor. The construction of the locking element 316 is exemplary and is not intended to be limiting of alternative constructions of 316, such as one or more pledgets, knots, barbs or other forms to effect the same function.

FIG. 38 shows the partial withdrawal of the fixation element delivery device once the fixation element has been deployed. In the illustrations shown, the final step during the pulling of finger grip 404 proximally results in the release of the fixation element in situ. The release may be accompanied by visual or tactile or auditory confirmation, such as a click. Once released, the fixation element delivery tool can be completely withdrawn as shown in FIG. 39, leaving the suture body 310 of a fixation element extending through the surgical incision 208. The proximal portion of suture body 310 may be cut to a suitable length with readily available surgical tools such as a scalpel or surgical scissors and removed from the surgical site. FIG. 43 shows a detail, sagittal view of a single deployed anchor band assembly 308 with T-anchor 316, pledget 309, slip knot 440 and associated tether components 318 and 310 (after it has been cut in the epi-annular space). Also shown are portions or sections of intervertebral disc tissues. As shown, fixation element 308 is fixedly engaged with the disc tissue and the patch 600. FIG. 40 depicts the treatment device 600 after placement of 2 fixation devices 308, as does FIG. 46 shown in a detail, sagittal view Of course, any number of fixation devices appropriate to secure the treatment device 600 can be used. It is also anticipated that device 600 may be of a construction and design, as described herein, that does not necessitate anchor bands to effect securement of device 600 within the disc space and therefore, illustrations using fixation elements are to be exemplary, and not limiting. Once secured, the treatment device 600 is released from the delivery tool 500. As illustrated here, this is accomplished in a two-step process. First the release mechanism is enabled by rotating knob 506 in the direction of arrows 312. An indicator may then be activated as shown by arrow 320 of indicator 508 in FIG. 41, such as spring-loaded release indicator 508 to notify the surgeon that the treatment device has been released from the delivery tool 500. Accompanying the deployment of indicator 508 is the uncoupling of the treatment device 600 at the distal end 602, as will be described in greater detail below. The delivery tool 500 can then be withdrawn as depicted in the transverse view of FIG. 41, leaving treatment device 600 in situ.

FIGS. 47-53 depict illustrative embodiments of an fixation element delivery tool (or FEDT) as discussed above, which may be referred to alternatively as an anchor band delivery tool (or ABDT). The fixation element 308 is depicted as loaded in the distal end 402 of the ABDT, which will be discussed in greater detail with reference to FIG. 48. The ABDT 400 is comprised of a main body member 410 which may be fixedly attached distally to outer cannula 422, and also to inner cannula 426 at inner cannula anchor 438. Distally, inner cannula 426, as better illustrated in detail in FIG. 48, may comprise a knot pusher (or other means to effect securement of suture tethers 310 and 318 with locking element 440) and T-anchor stand-off 434. Proximally, main body 410 has disposed safety member 406 with an outside diameter telescopically and rotatably received in the inner diameter of a knob 408. Knob 408 and main body member 410 are rigidly attached to one another Slidably disposed within the lumen of the main body member 410 is suture retention block 414, depicted with suture body 310 threaded through its center hole. A spring 316 is also slidably disposed within the lumen of the main body member and can abut either suture retention block 414 or slider member 418. Slider member 418 can be integral with finger grip 404 (not shown) as depicted in FIGS. 36-38. Attached to the proximal end of slider member 418 is a suture cutting blade assembly 420. The blade assembly, as will be discussed in greater detail below, serves to sever the suture body after deployment of the fixation elements as described herein. A slot in the slider member 418 allows the slider member 418 to slide past the outer cannula anchor 426 and, as described previously, 426 may be stationary with respect to main body 410. A slotted needle cannula 428, slidably disposed in the lumen of the outer cannula 422, is secured the distal end of slider member 418 by needle cannula anchor 430, such that the translation of the slider member 418 within main body member 410 concomitantly translates the slotted hypotube 428 within the outer cannula 422.

FIG. 48 is a detailed view of the distal end 402 of the ABDT 400. As described above, the slotted hypotube 428 is slidably received in the outer cannula 422. A tether, consisting of a suture line 318 and a pledget body 309 is located in proximity to an optional tissue stop 432 on the outer cannula 422. It is also possible for pledget 309 to be held by an optional outer cannula pledget holder 433 until release of the anchor band. The suture line 318 is slidably knotted to suture body 310. The distal end of suture body 310 is attached to T-anchor 316, which is held by T-anchor stand-off 434. As described above, T-anchor stand-off 434 and knot pusher 436 may be components of inner cannula 426. In the initial configuration, needle hypotube 428 extends distally of outer cannula 422 and allows the point of slotted hypotube 428 to extend distally of the T-anchor holder 434.

FIGS. 47 and 48 depict the ABDT in its initial delivery configuration. The ABDT is locked in this configuration by the distal end of safety 406 engaging the finger grip 404 (not shown) as depicted in FIGS. 36-38. Turning now to FIG. 36, the rotation of handle member 406 in the direction of arrow 306 allows the finger grip 404 (not shown) to engage a slot on safety 406, and permits the surgeon to pull finger grip 404 proximally toward the proximal knob 408. Doing so results in the translation of the slider member 418 proximally, and concomitantly, the proximal translation of the slotted needle cannula 426 (as a result of slotted needle cannula anchor 430) in the direction of arrow 326 (illustrated in FIG. 45). The result, as discussed above, is the unsheathing by the needle 428 of T-anchor 316 held by T-anchor holder 434. The translation of the slide body 418 proximally also urges the spring 416 and suture retention block 414 proximally. The suture retention block 414 is attached to suture body 310, and therefore tension is leveraged onto the suture body 310 to hold it taught and, when appropriate, draw T-anchor 316 from within the delivery tool to a position proximally.

FIGS. 50 and 51 illustrate the partial deployment of anchor band assembly from ABDT, wherein slotted needle cannula 428 has been partially retracted to expose T-anchor 316. FIG. 49 is a detail, cross sectional view of the distal end of the handle of ABDT 400, illustratively showing the inter-relationships of delivery tool components in the initial configuration and FIG. 52 is a similar detail, cross sectional view showing the inter-relationships after at least a partial deployment of device 400. FIG. 53 is a detail of the suture retention body 414, suture body 310, spring 316 and cutting assembly blade 420, during partial deployment of delivery tool 400, as discussed above.

As depicted in FIG. 54 and detail drawings of FIGS. 55 and 56, as slider body 418 continues to slide proximally, in addition to continuing to draw T-anchor as shown in FIG. 55 with arrows, the tether retention block 414 reaches the limit of it's proximal translation (discussed further below), and the slider member engages and compresses spring 316. As the spring is compressed, the blade assembly 420, which is aligned with the hole of suture retention body 414 through which suture body 310 passes, comes into engagement with the suture body 310. FIG. 56 is a detail view of the blade 420 severing the suture body 310. Up to the limit of travel of the suture block 414 and the severing of tether 310, the suture body 310 continues to apply tension to the T-anchor, as shown in greater detail in FIG. 55. With knot pusher holding knot 440, pledget 309, and suture 318 in apposition, and in distally exerted fashion, to the tensioning of suture body 310, anchor band assembly 308 is advantageously cinched into a fixing and/or compressive relationship between ends 309 and 316, as well as any structures (e.g., nucleus, annulus, treatment device) between elements 309 and 316. After severing suture body 310, suture body 310 is still attached, to the anchor band, but has at this point been severed proximally. The suture body 310 will therefore be unthreaded from the interior of the ABDT as the ABDT is withdrawn. As discussed above the suture line 310 may be further cut to length with readily available surgical scissors. Alternatively, a severing mechanism similar to those described herein in the distal portion of tool 400 may be employed to avoid an additional step of trimming the end of body 310.

FIG. 53 is a detail of the suture retention body 414, suture body 310, spring 316 and cutting assembly blade 420, during partial deployment of delivery tool 400, as discussed above

Additionally inventive of the anchor band device (and its delivery and deployment tools) is the unique inter-relationship of the slide body, spring, and the tension delivered to the T-anchor and tissue during deployment. For example, T-anchor assembly can be designed to pass through softer, or otherwise more pliable tissues (e.g., nucleus pulposus, softer annular layers) while resisting, under the same tension, passage through tougher tissues and/or substrates (e.g., outer annular layers, treatment device construct). In further illustrative description, tension delivered to the suture line 310 can be limited by the interface between the slide body member 318 and the suture retention block 414, through spring 316 such that tension is exerted on T-anchor body 316 which may sufficiently allow movement of T-anchor 316 through softer tissue, but alternatively requires a greater force to pull T-anchor body through other materials or substrates such as the treatment device 600 or outer layers of the annulus 202. Spring 316 can be designed to sufficiently draw tissues and/or the patch together, while not overloading suture line 310 when the fixation has been effected. Spring 316 may also be advantageously designed to allow blade assembly 420, upon reaching an appropriate loading to effect the delivery, to sever the suture line 310. As illustrative example, but not intended to be limiting, T-anchor body and suture line may be constructed to require approximately 5 pounds of force to draw the T-anchor assembly through nuclear tissue, but substantially greater load to draw T-anchor through annular tissue and/or patch device. Spring may be designed to exert approximately 5 pounds, sufficiently pulling anchor through nuclear tissue, and in proximity to treatment device, as intended. Once sufficient load has been applied to move T-anchor to engage patch, the loading on the suture line is not allowed to substantially increase. Advantageously, additional loading would cause the final compression of spring between suture retention block and blade assembly to sever suture line. Preferably, the severing and the design of the tether elements are such that the ultimate strength of the suture line is greater than the load required to draw T-anchor through soft tissue, or the like, and less than the load inflicted to cause the severing by blade assembly. The description herein is intended to be illustrative and not limiting, in that other device and delivery tools could be derived to employ the inventive embodiments.

FIGS. 57-62 depict illustrative embodiments of a therapeutic device delivery tool (TDDT), or mesh delivery tool (or MDT) as discussed above. The treatment device (or mesh or patch) 600 is depicted as loaded in the distal end of the TDDT 500, which will be discussed in greater detail with reference to FIG. 58. The TDDT 500 is comprised of a main body housing 510 which may be fixedly attached distally to outer cannula 522, which in a lumen thereof slidably receives a holding tube assembly 526. Distally, holding tube 526, as better illustrated in detail in FIG. 58, may comprise a slotted end and accommodate an actuator rod or stylet 514 in an inner lumen. Proximally, main body 510 has disposed thereon safety member 504, and has an outside diameter telescopically and rotatably received in the inner diameter of cap 506. Cap 506 forms part of end cap assembly 524, which also comprises ball plunger assembly 536, which will be described in greater detail below. Slidably disposed within the lumen of the main body member 510 is actuator body assembly 518, which abuts at its distal end, optionally in mating fashion or via detents, against a proximal end of finger grip member 502, which his is also slidably disposed in the lumen of main body 510. At the proximal end of the actuator body assembly 518 is formed device release indicator 508, which will be described in greater detail below. A spring 516 is also slidably disposed within the lumen of the main body member and can abut either actuator body assembly 518 or finger grip member 502. The finger grip member can optionally comprise finger members at a distal end, carrying detents to engage with tabs, slots, or other cooperative structure on the inner lumen of main body 510 to lock the finger grip member, aggressively or gently, in the undeployed (unused) or deployed (used) configuration. A holding tube assembly, in the form of a slotted hypotube needle cannula 526, is slidably disposed in the lumen of the outer cannula 522, and is secured to the distal end of actuator body assembly 518, such that the translation of the finger grip member 502 proximally within main body member 510 concomitantly translates the actuator body assembly 518, and thus holding tube assembly 526 within the outer cannula 522.

FIG. 58 is a detailed view of the distal end 602 of the TDDT 500. As described above, the holding tube assembly 526 is slidably received in the outer cannula 522. The TDDT is designed to releasably deploy the treatment device 600 after the distal end 602 is navigated by the surgeon to the intended deployment site. The treatment device 600, shown in cross section and discussed further below, comprises a proximal end, forming a collar or cuff 604, and a distal end, also forming a collar or cuff 606. The proximal end 604 is slidably disposed on holding tube assembly 526, and abuts and is held stationary by outer cannula 522. The distal end of the holding tube assembly 526 can be formed to carry treatment device latch 608. The device latch 608 is formed with a flange or other detent to engage the distal end of treatment device 600, preferable the distal most end of distal collar 606. The slotted end of holding tube assembly 526 is held radially rigid by actuation rod 514, such that the treatment device 600 is held firmly on the distal end 602 of the TDDT 500.

FIGS. 57 and 58 depict the TDDT in its initial delivery configuration. FIG. 67 depicts the treatment device delivery tool 500 of FIG. 57 with an additional inventive embodiment of delivery support elements 540. One end of each delivery support element 540 (illustratively FIG. 67 reveals two delivery support elements) may be fixedly attached to the proximal portion of the delivery tool 500 and may be actuated by, for example, finger grip 502. The other end of the delivery support element —540′—may be releasable attached to the proximal end of the delivery tool 500. For example, 540′ is temporarily affixed in between the junction of actuator body 518 and finger grip 502 in FIG. 67. Initially, with or without the additional use of delivery support members, the TDDT of FIGS. 57 and 58 is locked in this configuration by the distal end of safety 506 engaging the finger grip 502. Turning now to FIG. 59, the rotation of safety 506 in the direction of arrow 302 allows the finger grip 502 to engage a slot on safety 506, and permits the surgeon to pull finger grip 502 proximally in the direction of arrow 300 toward the proximal cap 506. Doing so results in the translation of the slider member 518 proximally, and concomitantly, the proximal translation of the holding tube assembly 526. The result, as further illustrated in FIG. 60, is the movement of the distal end 606 of treatment device 600 moving toward the proximal end 604, resulting in a bulging or lateral expansion of the treatment device 600. The translation of the actuator body assembly 518 proximally also urges the device release indicator 508 proximally, as will be discussed further below. As can be seen in FIG. 68, the delivery of treatment device may be enhanced with delivery support elements 540, which also move with slider member 518 and finger grip 502 and result in the delivery of the treatment device as seen in FIG. 69.

FIG. 60 depicts the distal end of the TDDT 500 after fully withdrawing the finger grip member 502 proximally, as discussed above (or FIG. 69 for enhanced delivery with delivery support members). When the finger grip has reached the limit of its intended travel upon being pulled by a surgeon, the treatment device 600 will be in its deployed configuration. In this configuration, detents on the proximal end of treatment device latch 608 will be poised to engage the proximal end 604 of treatment device 600 to hold it in the deployed state. As illustrated in FIG. 60, the actuation rod 514 can be seen to hold the distal end of the holding tube assembly 526 engaged with the distal end 606 of the treatment device 600, providing for maneuverability or removal until released.

FIGS. 61 and 62 illustrate the final deployment of the treatment device 600 just prior to withdrawal of the TDDT. As shown in FIG. 61, the rotation of cap 506 in the direction of arrow 312 releases actuator body assembly 518 from ball plunger 536, permitting its translation proximally under the bias of spring 516. Translation of the actuator body assembly 518 withdraws actuator rod 514 in the proximal direction, which permits the release of the treatment device 600 from the distal end of the TDDT, as further described with reference to FIG. 62. The translation proximally of actuator body assembly 518 permits indicator 508 to emerge from a hole in the cap 506, providing a perceptible indication to the surgeon that the TDDT can be removed and will leave the treatment device in situ. Turning to FIG. 62, the withdrawal of the actuation rod 514 is illustrated, which allows for inward radial compression of the tip of the holding tube assembly 526. Once the distal end of the holding tube assembly 526 is compressed radially inwardly, it can then pass through the inner diameter of the treatment device latch 608, and allow withdrawal of the entire TDDT from the treatment device 600. The final disengagement of the distal end of the outer cannula 522 can advantageously permit the engagement of detents on the treatment device latch 608 to engage the proximal collar 604 of the treatment device 600, locking it in a deployed configuration.

In an alternative embodiment utilizing an enhanced delivery of a treatment device, FIGS. 70 and 71 depict the final configurations of a delivery tool 500 with delivery support elements 540. FIG. 70 illustrates the release of the releasable end of support element 540′ from the juncture between the actuator body 518 and the finger grip 502 after rotation of knob 506. Free ends of support elements 540′ may now travel distally down along the shaft of the delivery tool, through the mesh implant, and be releasably detached from the delivered mesh. FIG. 71 shows the motion 542 of the end of support element 540′ passing distally through the mesh as the delivery tool is being withdrawn from the treatment device. In this embodiment, delivery support elements are removed from the treatment device after its acute placement.

Additionally inventive of the treatment device (and its delivery and deployment tools) is the unique inter-relationship of the actuator body, spring, and the holder tube assembly, allowing the device to be deployed while still holding the device firmly during deployment. The use of the actuator rod to stiffen the distal end of the small diameter outer cannula, and the use of a radially compact treatment device offers additional advantages, such as the ability to pass through softer, or otherwise more pliable tissues (e.g., nucleus pulposus, softer annular layers) while resisting columnar bending during navigation. As an illustrative embodiment, a mesh patch as described in FIGS. 63 and 64 can be employed, but such a device configuration is not intended to be limiting. Other devices that expand radially through linear actuation can also be used.

The spring may be designed to exert approximately 5 pounds, sufficient to provide tactile control while preventing inadvertent release of the treatment device. By requiring actuation of the device in a different direction for release (i.e., rotation of the proximal cap) than that required for initial deployment (i.e., proximal translation of the finger grip), each with tactile, auditory or visually perceptible confirmation, safe an affirmative deployment can be achieved.

FIGS. 63 and 64 depict anterior views of the distal end 602 of the TDDT and treatment device 600 following deployment. FIG. 63 shows the distal end of holding tube assembly 526 engaging the treatment device latch 608. FIG. 64 shows the distal end of 526′ disengaged, following withdrawal of the actuation rod 514 as discussed hereinabove.

FIG. 72 illustrates a further embodiment of an enhanced delivery of a treatment device 600 through the use of delivery support elements 540 and a support element collar 544. Support element collar 544 may act to hold the support elements distally and to guide elements' travel along the shaft of the treatment device delivery tool 500. The collar may be constructed to allow the support elements to movable pass through the collar, and thus the collar may remain relatively stationary along the TDDT shaft, or conversely, the collar may be affixed to the elements and be movable along the TDDT shaft. It is also contemplated that the collar could have a limited dimension along the shaft, serving principally as a guide for support elements 540; or conversely, collar 544 could extend along a significant portion of the shaft of delivery tool 500, resembling a tube along the outer shaft of delivery tool 500. The latter construction may provide increased leverage and support to the delivery support elements. It is contemplated that a variety of biocompatible materials may be used to construct the collar, such as, but not limited to: polymers, metals, ceramics, synthetics, engineered, shape memory, biodegradable/bioresorbable.

Exemplary delivery support elements 540 have been characterized previously, for exemplary reasons only, as sutures; although, it is contemplated that the construction of the support elements may take various forms such as rods, beams, bars, wires, bands, tubes or other actuating elements to assist in the deployment, opening, seating or otherwise delivery of a treatment device. For example, FIG. 73 depicts a device support element constructed of a tube and an attachment element 548 to releasably attach the support element 540 to the treatment device. The attachment element 548 is released after the delivery of the treatment device and the support element is removed with the TDDT 500. It is also anticipated that attachment element may take a variety of forms to allow attachment of support element 540 to treatment device 600, including but not limited to: hooks, latches, knots, clips, grips, fasteners, pins, staples, clasps, slides or other attachment means. Support elements and collars may be comprised of a variety of biocompatible materials, including, but not limiting: polymers, metals and metallic alloys, ceramics, synthetics, engineered, shape memory, biodegradable/bioresorbable.

In addition to delivery support elements that are releasably attached to the treatment device 600, and therefore may be removed with the delivery device 500, it is contemplated that some embodiments of the invention may include delivery support elements that may partially, or wholly, remain an integral part of the implanted treatment device. For example, FIG. 74 depicts an exemplary embodiment wherein a support element may be constructed of, for example, a suture with knots along its length. One end of the suture is affixed to a distal end of the treatment device. Proximally, the proximal end of treatment device may have delivery support element latch 546 configured to lockingly receive portions of a support element 540. When support element 540 of FIG. 74 is drawn proximally in a direction depicted by arrow 542, while the treatment device is deployed, elements along 540 may engage with the proximal portion of the treatment device to secure support elements when the treatment device is in an expanded configuration. As illustrated, a suture line with knots is depicted to illustrate the use of an embodiment of support elements that may remain with the treatment device after deployment, however there may be a variety of different constructions of a support element 540 as well as means to lockingly attach the support element to the treatment device, utilizing for example, hooks, latches, anchors, clips, grips, fasteners, pins, staples, clasps, slides, or other attachment means. These support elements may be formed from a variety of biocompatible materials including, but not limiting: polymers, metals, biodegradable/bioresorbable, natural, synthetic, genetically engineered.

An additional exemplary embodiment of a support element that may be an integral portion of treatment device can be seen in FIG. 75. Delivery support elements 540 assist in the opening, deployment, seating and otherwise delivery of treatment device 600. Support elements 540 may be constructed of an elastic material, allowing the device to obtain the configuration in FIG. 75 when the device is deployed. Elements 540 act as “tension bands” to support the opening of the device and provide tension when “seating” the device against tissue. Elements may be constructed of a variety of biocompatible materials, such as: polymers, metals, synthetic, natural, engineered, superelastic alloys, shape memory, biodegradable/bioresorbable, etc.

Since the surgeon's visualization of during discectomy procedures is typically limited to the epi-annular space and the aperture at the outside surface of the annulus, any tactile, visual or audible signals to assist, or otherwise enhance, the surgeon's ability to reliably deliver and deploy treatment devices may be advantageous. Assisting the delivery with the inventive enhanced delivery embodiments with delivery support elements described herein may allow for increased reliability of delivery and fixation of a treatment device for the repair of annular tissue. Exemplary materials that could be used to construct the various delivery support elements, collars, attachment elements include, but are not limited to: biocompatible polymeric materials (polyester, polypropylene, polyethylene, polyimides and derivatives thereof (e.g., polyetherimide), polyamide and derivatives thereof (e.g., polyphthalamide), polyketones and derivatives thereof (e.g., PEEK, PAEK, PEKK), PET, polycarbonate, acrylic, polyurethane, polycarbonate urethane, acetates and derivatives thereof (e.g., acetal copolymer), polysulfones and derivatives thereof (e.g., polyphenylsulfone), or biocompatible metallic materials (stainless steel, nickel titanium, titanium, cobalt chromium, platinum and its alloys, gold and it alloys), or biodegradeable/bioresorbable materials, or naturally or synthetically derived materials.

All patents referred to or cited herein are incorporated by reference in their entirety to the extent they are not inconsistent with the explicit teachings of this specification, including; U.S. Pat. No. 5,108,438 (Stone), U.S. Pat. No. 5,258,043 (Stone), U.S. Pat. No. 4,904,260 (Ray et al.), U.S. Pat. No. 5,964,807 (Gan et al.), U.S. Pat. No. 5,849,331 (Ducheyne et al.), U.S. Pat. No. 5,122,154 (Rhodes), U.S. Pat. No. 5,204,106 (Schepers at al.), U.S. Pat. No. 5,888,220 (Felt et al.),U.S. Pat. No. 5,376,120 (Sarver et al.) and U.S. Pat. No. 5,976,186 (Bao et al.).

Various materials know to those skilled in the art can be employed in practicing the present invention. By means of example only, the body portions of the stent could be made of NiTi alloy, plastics including polypropylene and polyethylene, polymethylmethacrylate, stainless steel and other biocompatible metals, chromium cobalt alloy, or collagen. Webbing materials can include silicone, collagen, ePTFE, DACRON, polyester, polypropylene, polyethylene, and other biocompatible materials and can be woven or non-woven. Membranes might be fashioned of silicone, polypropylene, polyester, SURLYN, PEBAX, polyethylene, polyurethane or other biocompatible materials. Inflation fluids for membranes can include gases, liquids, foams, emulsions, and can be or contain bioactive materials and can also be for mechanical, biochemical and medicinal purposes. The stent body, webbing and/or membrane can be drug eluting or bioabsorbable, as known in the medical implant arts.

Further, any of the devices or delivery tools described herein, or portions thereof, could be rendered visible or more visible via fluoroscopy, if desired, through the incorporation of radiopaque materials or markers. Preferably implantable devices are constructed with MRI compatible materials. In particular, devices and/or their components could be wholly or partially radiopaque, as result of, for example: compounding various radiopaque materials (e.g., barium sulphate) into device materials; affixing radiopaque materials to device structures (e.g., bands of platinum, gold, or their derivative alloys); deposition of radiopaque materials onto device structures (e.g., deposition of platinum, gold of their derivative alloys); processing radiopaque materials into device structures (e.g., braiding/weaving platinum or gold wires or its alloy derivatives). One inventive way to achieve radiopacity of a device described herein, for example treatment device 600, is placing one or more radiopaque marker bands onto filaments of braided device 600 before (or possibly after) creating end potions of the device.

Other embodiments of the invention will be apparent to those skilled in the art from consideration of the specification and practice of the invention disclosed herein. It is intended that the specification and examples be considered as exemplary only, with a true scope and spirit of the invention being indicated by the following claims.

Claims

1. A method for deploying a therapeutic device to treat intervertebral disc tissue comprising:

providing a therapeutic device and a longitudinal delivery tool having a proximal end and a distal end, the therapeutic device releasably attached to the distal end of said tool, said tool comprising: at least one proximal actuating member; and at least one delivery support element connected to the therapeutic device in a first, pre-deployment configuration, and adapted to facilitate lateral deployment of the therapeutic device from the longitudinal axis of the delivery tool; said at least one delivery support element movable in the longitudinal direction under tension to facilitate lateral expansion and deployment of the therapeutic device in a second, post-deployment configuration, wherein the therapeutic device is attached to the distal end of the delivery tool in the first, pre-deployment configuration;
inserting the therapeutic device into the intervertebral disc;
at least partially actuating the at least one proximal actuating member so that said therapeutic device begins to laterally expand;
moving said at least one delivery support element in the proximal direction under tension thereby allowing or causing said therapeutic device to further laterally expand relative to the longitudinal axis of the delivery tool so as to be deployed proximate to intervertebral disc tissue;
deploying said therapeutic device in the second, post-deployment configuration; and
removing said longitudinal delivery tool.

2. The method according to claim 1, further comprising a step of preparing intervertebral disc tissue, wherein said step of preparing comprises:

identifying a damaged section of tissue; and
removing the damaged section of tissue.

3. The method according to claim 1, wherein said step of inserting the therapeutic device comprises making a surgical incision into intervertebral disc tissue to provide access into intervertebral disc tissue.

4. The method according to claim 1, wherein said at least one delivery support element comprises a suture line having a first end and a second end.

5. The method according to claim 4, wherein the first end and the second end of said suture line are attached to the proximal actuating member of said delivery tool.

6. The method according to claim 4, wherein the first end is attached to the proximal actuating member of said delivery tool, and the second end is attached to the proximal end of said delivery tool.

7. The method according to claim 4, wherein the first end is attached to a first proximal actuating member and the second end is attached to a second proximal actuating member.

8. The method according to claim 4, wherein said longitudinal delivery tool further comprises a finger grip assembly, wherein said proximal actuating member abuts said finger grip assembly, and wherein the second end is releasably affixed to a juncture between the proximal actuating member and the finger grip assembly.

9. The method according to claim 4, wherein said suture line extends from said tool through a therapeutic device releasably attached to the distal end of said tool.

10. The method according to claim 4, wherein the second end of said suture line is releasable from said delivery tool.

11. The method according to claim 1, wherein said longitudinal delivery tool comprises two or more delivery support elements.

12. The method according to claim 1, wherein said at least one delivery support element is releasable from said delivery tool.

13. The method according to claim 1, wherein said at least one delivery support element is constructed from biocompatible polymeric materials, polyamide, polyamide derivatives, polyketones, polyketone derivatives, PET, polycarbonate, acrylic, polyurethane, polycarbonate urethane, acetates, acetate derivatives, polysulfones, polysulfone derivatives, biocompatible metallic materials, biodegradable/bioresorbable materials, naturally derived materials, or synthetically derived materials.

14. The method according to claim 1, wherein said longitudinal delivery tool further comprises at least one delivery support element collar configured to distally hold said at least one delivery support element.

15. The method according to claim 14, wherein said at least one delivery support element collar is configured to allow said at least one delivery support element to movably pass through said collar.

16. The method according to claim 14, wherein said at least one delivery support element collar is affixed to said delivery tool.

17. The method according to claim 14, wherein said at least one delivery support element collar is movable in the longitudinal direction, wherein said method further comprises moving said at least one delivery support element collar in the longitudinal direction.

18. The method according to claim 14, wherein said at least one delivery support element collar comprises a tube affixed to the shaft of said tool.

19. The method according to claim 14, wherein said at least one delivery support element collar is constructed from a biocompatible material.

20. The method according to claim 19, wherein said biocompatible material is a polymer, a metal, a metallic alloy, a ceramic, a synthetic material, an engineered material, a shape memory material, or a biodegrable/bioresorbable material.

21. The method according to claim 1, wherein said at least one delivery support element comprises a tether, a rod, beam, wire, band, tube, or actuating element.

22. The method according to claim 1, wherein said at least one delivery support element comprises a suture line having at least on knot along its length.

23. The method according to claim 1, wherein said at least one delivery support element is integrated with the therapeutic device.

24. The method according to claim 1, wherein at least a portion of said at least one delivery support element is exterior to said delivery tool.

25. The method according to claim 1, further comprising releasing said at least one delivery support element from said longitudinal delivery device.

26. A method for deploying a therapeutic device to treat intervertebral disc tissue comprising:

providing a therapeutic device and a longitudinal delivery tool having a proximal end and a distal end, the therapeutic device releasably attached to the distal end of the delivery tool and including a proximal end, a distal end, and an intermediate portion between the proximal and distal ends, the proximal and distal ends of the therapeutic device having a fixed outer dimension such that they are not laterally expandable, the intermediate portion being laterally expandable, the tool comprising: at least one proximal actuating member; and at least one delivery support element connected to the therapeutic device in a first, pre-deployment configuration, and adapted to facilitate lateral deployment of the intermediate portion of the therapeutic device from the longitudinal axis of the delivery tool; the at least one delivery support element movable in the longitudinal direction under tension to facilitate lateral expansion and deployment of the therapeutic device in a second, post-deployment configuration, wherein the therapeutic device is attached to the distal end of the delivery tool in the first, pre-deployment configuration;
inserting the therapeutic device into the intervertebral disc;
at least partially actuating the at least one proximal actuating member to urge the proximal and distal ends of the therapeutic device toward one another so that the intermediate portion of said therapeutic device begins to laterally expand;
moving the at least one delivery support element in the proximal direction under tension thereby allowing or causing the intermediate portion of the therapeutic device to further laterally expand relative to the longitudinal axis of the delivery tool so as to be deployed proximate to intervertebral disc tissue;
deploying the therapeutic device in the second, post-deployment configuration; and
removing the longitudinal delivery tool.

27. The method according to claim 26, wherein the at least one delivery support element comprises a suture line having a first end and a second end.

28. The method according to claim 27, wherein the first end and the second end of the suture line are attached to the proximal actuating member of the delivery tool.

29. The method according to claim 27, wherein the first end is attached to the proximal actuating member of said delivery tool, and the second end is attached to the proximal end of said delivery tool.

30. The method according to claim 27, wherein the first end is attached to a first proximal actuating member and the second end is attached to a second proximal actuating member.

31. The method according to claim 27, wherein the longitudinal delivery tool further comprises a finger grip assembly, wherein the proximal actuating member abuts the finger grip assembly, and wherein the second end is releasably affixed to a juncture between the proximal actuating member and the finger grip assembly.

32. The method according to claim 27, wherein the suture line extends from the delivery tool through a therapeutic device releasably attached to the distal end of the delivery tool.

33. The method according to claim 27, wherein the second end of the suture line is releasable from the delivery tool.

34. The method according to claim 26, wherein the longitudinal delivery tool comprises two or more delivery support elements.

35. The method according to claim 26, wherein the at least one delivery support element is releasable from the delivery tool.

36. The method according to claim 26, wherein the at least one delivery support element is constructed from biocompatible polymeric materials, polyamide, polyamide derivatives, polyketones, polyketone derivatives, PET, polycarbonate, acrylic, polyurethane, polycarbonate urethane, acetates, acetate derivatives, polysulfones, polysulfone derivatives, biocompatible metallic materials, biodegradable/bioresorbable materials, naturally derived materials, or synthetically derived materials.

37. The method according to claim 26, wherein the longitudinal delivery tool further comprises at least one delivery support element collar configured to distally hold the at least one delivery support element.

38. The method according to claim 37, wherein the at least one delivery support element collar is configured to allow the at least one delivery support element to movably pass through said collar.

39. The method according to claim 37, wherein the at least one delivery support element collar is affixed to the delivery tool.

40. The method according to claim 37, wherein the at least one delivery support element collar is movable in the longitudinal direction, wherein the method further comprises moving the at least one delivery support element collar in the longitudinal direction.

41. The method according to claim 37, wherein the at least one delivery support element collar comprises a tube affixed to the shaft of the tool.

42. The method according to claim 37, wherein the at least one delivery support element collar is constructed from a biocompatible material.

43. The method according to claim 42, wherein the biocompatible material is a polymer, a metal, a metallic alloy, a ceramic, a synthetic material, an engineered material, a shape memory material, or a biodegrable/bioresorbable material.

44. The method according to claim 26, wherein the at least one delivery support element comprises a tether, a rod, beam, wire, band, tube, or actuating element.

45. The method according to claim 26, wherein the at least one delivery support element comprises a suture line having at least on knot along its length.

46. The method according to claim 26, wherein the at least one delivery support element is integrated with the therapeutic device.

47. The method according to claim 26, wherein at least a portion of the at least one delivery support element is exterior to the delivery tool.

48. The method according to claim 26, further comprising releasing the at least one delivery support element from the longitudinal delivery device.

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Patent History
Patent number: 7935147
Type: Grant
Filed: Sep 26, 2005
Date of Patent: May 3, 2011
Patent Publication Number: 20070198021
Assignee: Anulex Technologies, Inc. (Minnetonka, MN)
Inventor: Lawrence W. Wales (Maplewood, MN)
Primary Examiner: Eduardo C Robert
Assistant Examiner: Elana B Fisher
Attorney: Faegre & Benson LLP
Application Number: 11/235,764
Classifications
Current U.S. Class: Including Spinal Disc Spacer Between Adjacent Spine Bones (623/17.16)
International Classification: A61F 2/44 (20060101);